Winchester Neurologist & Valley Health Collaborate To Offer New Drug for Children with Treatment-Resistant Epilepsy

News2015JanuaryWinchester Neurologist & Valley Health Collaborate To Offer New Drug for Children with Treatment-Resistant Epilepsy

Winchester Neurologist & Valley Health Collaborate To Offer New Drug for Children with Treatment-Resistant Epilepsy

January 21, 2015

The Virginia Comprehensive Epilepsy Program and Valley Health’s Clinical
Research Department are conducting a clinical trial using Epidiolex®
for two children with catastrophic forms of epilepsy who were not responding
to other drugs. Eight weeks after beginning the drug trial in November,
the team is optimistic.

Epidiolex is a liquid formulation of pure Cannabidiol (CBD) derived from
the cannabis plant. Pioneered by GW Pharmaceuticals, Epidiolex is the
first-of-its-kind form of CBD which contains no tetrahydrocannabinol (THC),
the major psychoactive ingredient in marijuana. GW Pharmaceuticals, headquartered
in the UK, is providing Epidiolex under an “expanded access program”
authorized by the Food & Drug Administration (FDA). It is the only
company in the world that produces pharmaceutical grade pure plant-derived
CBD, which can administered orally as a suspension or via feeding tube.

Initial trials of Epidiolex have shown promising signs of efficacy and
safety in children with treatment-resistant epilepsy.

“We are excited to be involved in research that will further determine
if these patients will experience a reduction in their seizures and an
improved quality of life,” said Paul D. Lyons, MD, PhD, adult and
pediatric epileptologist with Winchester Neurological Consultants and
principal investigator for the study. “Children with refractory
epilepsy face particular challenges as their seizures are extremely difficult
or impossible to control. This significantly impacts the child's ability
to lead a normal life and is a challenge for the entire family.”

An attending physician at Winchester Medical Center, Dr. Lyons is Medical
Director of the Virginia Comprehensive Epilepsy Program, one of the country’s
few Level 4 epilepsy programs within a community hospital. The program
incorporates neurosurgery, nutrition support and other services.

Beginning in October 2014, another clinical trial began enrolling at a
select number of hospital sites to determine the correct dosages for Epidiolex
in patients with Dravet syndrome. This syndrome occurs in about one in
every 30,000 births. Children with Dravet face a diminished quality of
life and may experience dozens or even hundreds of seizures per day. These
patients are also prone to prolonged life-threatening seizures called
status epilepticus. Seizures in children with Dravet syndrome are often
not responsive to currently available medications and are difficult to
control. These children often struggle with developmental delays, a variety
of health problems and have an increased risk of Sudden Unexplained Death
in Epilepsy (SUDEP).

Beginning in the first quarter of 2015, Dr. Lyons and his research team
will participate in the next phase of this program, evaluating Epidiolex
in treating Dravet syndrome and Lennox Gastaut syndrome (LGS).

About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on discovering,
developing and commercializing novel therapeutics from its proprietary
cannabinoid product platform in a broad range of disease areas. GW commercialized
the world’s first plant-derived cannabinoid prescription drug, Sativex®,
which is approved for the treatment of spasticity due to multiple sclerosis
in 27 countries outside the United States. Sativex is also in Phase 3
clinical development as a potential treatment of pain associated with
advanced cancer. GW is also advancing an orphan drug program in the field
of childhood epilepsy with a focus on Epidiolex®, which is in Phase
2/3 clinical development for the treatment of Dravet syndrome and which
is also expected to enter Phase 3 clinical trials in the treatment of
Lennox-Gastaut syndrome. GW has a deep pipeline of additional cannabinoid
product candidates which includes compounds in Phase 1 and 2 clinical
development for glioma, ulcerative colitis, type 2 diabetes, and schizophrenia.
For further information, please visit www.gwpharm.com.

About Virginia Comprehensive Epilepsy Program
The Virginia Comprehensive Epilepsy Program (VCEP), designated a Level
4 program by the National Association of Epilepsy Centers, is a partnership
between Winchester Medical Center, Winchester Neurological Consultants
and Virginia Brain & Spine. VCEP provides care for children and adults,
with epileptologists Paul Lyons, MD, and J. Craig Henry, MD; neurosurgeon
Lee Selznick, MD; ketogenic diet specialist Laila Hammer, RD; and other
support services. Winchester Medical Center, a 445-bed regional referral
facility, is the largest of the six hospitals of the not-for-profit Valley
Health System. Over 350 physicians provide a full range of medical, surgical,
diagnostic and rehabilitation services to a tri-state area of more than
400,000 residents. Since 2004 the Valley Health Clinical Research Department
has managed more than 100 clinical trials to investigate the efficacy
of new drugs and devices before they are approved for use in the U.S.
Current trials focus on neurology, cardiology and infectious disease.
For more information on epilepsy care, visit www.valleyhealthlink.com/epilepsy.